Lidocaine Administration Using STAR Particles

Not Applicable

Completed

Interventions: Device: LET Gel after STAR Particle Application (Right or Left Arm)
Other: LET Gel Application without STAR Particle Application (Contralateral Arm)

Brief Summary: This study is being done to answer the question: Do STAR particles (tiny pieces of ceramic with small spikes) help numbing gel (a gel that helps you feel less pain) work more quickly to provide local anesthesia or numbing in a specific area? Research participants will provide feedback on how quickly the STAR particles with the numbing gel can provide anesthesia. Participants will report their sensation at either 10 or 20 minutes after application of the numbing gel.

Detailed Description: This study aims to find out if the combination of STAR particles with numbing gel can deliver anesthesia faster than applying the gel by itself. STAR particles are very small particles with microneedles on the surface that can increase and create small punctures in the skin. The small punctures should allow for the numbing gel to work more quickly and allow the area to become numb more quickly.

After pretreatment with STAR particles (applied to the right or left arm) and aloe gel (used as a control condition in the contralateral arm) a numbing gel will be applied. A Pin-Prick test will be performed to evaluate local anesthesia from the numbing gel; half the participants will be evaluated 10 minutes after application of the numbing gel and the other half will be assessed 20 minutes after the numbing gel is applied. The study team will also assess pain after needle insertion and measure how much water is being lost from the skin using a device called a Vapometer before and after the STAR particle and aloe gel applications. Participants will have follow-up calls 24 hours and 1 week after the visit to ask about any changes to the skin where the STAR particles were applied.

Recruitment & Eligibility

Inclusion Criteria

Children, adolescents, and young adults, 10 to 21 years of age
In good general health as determined by a medical history
Willing to provide informed assent with parental consent and follow study requirements

Exclusion Criteria

Is chronically using pain medication
Has a plan to move to another location in the next 12 months or foresees any other reason that participation in the study would be disrupted during the next 12 months
Has skin disorders or skin allergies
Has any previous allergy or adverse reaction to STAR particle ingredients (Titanium Dioxide)
Has abnormal (e.g., tattooed) skin at proposed the site(s) of STAR particle application
Has known neurological conditions that might affect sensory function or perception of pain
Has any condition (social or medical), which in the opinion of the investigator would make study participation unsafe, would interfere with adherence to the clinical study requirements, or would complicate data interpretation

Arm && Interventions

Group	Intervention	Description
Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application	LET Gel Application without STAR Particle Application (Contralateral Arm)	Children, adolescents, and young adults will receive local anesthesia with lidocaine-epinephrine-tetracaine (LET) gel via different methods on different arms. One arm will have STAR particles used prior to LET gel and the other arm will have aloe gel applied prior to LET gel.
Lidocaine-epinephrine-tetracaine (LET) Gel After and Without STAR Particle Application	LET Gel after STAR Particle Application (Right or Left Arm)	Children, adolescents, and young adults will receive local anesthesia with lidocaine-epinephrine-tetracaine (LET) gel via different methods on different arms. One arm will have STAR particles used prior to LET gel and the other arm will have aloe gel applied prior to LET gel.

Primary Outcome Measures

Name	Time	Method
Application Site Pain Assessment	Day 1 at 10 minutes or 20 minutes after application of LET gel	The application site pain assessment was measured by using the visual analog scale (VAS). The VAS consists of a 10 centimeter (cm) line with opposite endpoints representing "no pain" (coded as 0) and "pain as bad as it could possibly be" (coded as 10).
Percent of Sharp (as Opposed to Dull) Sensation Over Application Area	Day 1 at 10 minutes or 20 minutes after application of LET gel	The time to achieve anesthesia is assessed as the percent of sharp (as opposed to dull) sensation reported at 10 or 20 minutes after the application of LET gel.

Secondary Outcome Measures

Name	Time	Method
Change in Transepidermal Water Loss (TEWL)	Day 1 at baseline and immediately after application of LET gel	The transepidermal water loss (TEWL) was measured before and after application of the STAR particles and compared to the TEWL measurement before and after application of the aloe gel.
Number of Participants Experiencing Serious Adverse Events	Immediately after application, 1 hour after application and up to 1 week after application	All serious adverse events were documented starting immediately after lidocaine application up to one week after application.
Number of Participants Experiencing Adverse Events	Immediately after application, 1 hour after application and up to 1 week after application	All adverse events were documented starting immediately after lidocaine application up to 1 week after application.
Number of Participants With Acute Skin Reactions (ASRs)	Immediately, 1 hour, 24 hours, and 7 days after application.	Participants were observed for acute skin reactions at each application site on both arms.